This section is intended to introduce the reader to various aspects of the art that may be related to various aspects of the present invention. The following discussion is intended to provide information to facilitate a better understanding of the present invention. Accordingly, it should be understood that statements in the following discussion are to be read in this light, and not as admissions of prior art.
Patients with severe Right-sided circulatory/Right Ventricular Failure have a significantly high mortality and morbidity caused by a multitude of factors in multiple patient populations. Historically, Right Ventricular Assist Devices have been placed for surgical patients, without a percutaneous or Cath lab option available. These surgical RVAD's have been placed for patients with right inferior myocardial infarction, acute right-sided ischemic myocardial, infarctions (with large left and right propagation), Cardiogenic Shock, LVAD created RV dysfunction, post transplant RV failure and pulmonary hypertension. Acute myocardial infarction and Cardiogenic shock have been treated with IABPs and maximal inotropic support, to which many patients become refractory to these treatment options. Surgically implanted LVADs can create a significant septal shift that leads to a dynamic change in the Starling curve that abruptly places patients into severe RV Failure. Patients bridged to transplant to from an LVAD with severe RV failure, can limit post transplant survival. Secondary Pulmonary Hypertension leads to an exacerbation of RV failure in acute and chronic situations, which are commonly treated with LVADs.
The present invention, often referred to as a TandemHeart Transseptal Cannula EF 72, has the capabilities to reach the Pulmonary Artery from the Femoral Veins via a percutaneous insertion. Traditional RVADs have a cannula either primarily placed in the PA or a graft sewn onto the PA, then a cannula inserted through the graft. The THTC-EF 72 can be quickly visualized in the PA via Fluoroscopy and X-Ray with the aid of the distal markers in the cannula, verifying the proper orientation of the outflow to the patient.
The THTC-EF 72 facilitates greater usage of the TandemHeart System in a wider population of patients requiring Left-sided extracorporeal circulatory support. Torso length can limit the ability to access the Left Atrium via percutaneous insertion. The THTC-EF 72 can be utilized by either the Left or Right Femoral Vein, optimizing placement. Venous and Arterial blood mixing in patients can lead to an increase of morbidity and mortality.
Furthermore, traditional venoarterial ECMO (VA ECMO) is the current standard of care used to treat right ventricular failure and respiratory failure percutaneously. VA ECMO takes blood from the right atrium and pumps it through an oxygenator and back into the arterial circulation via the femoral artery. VA ECMO bypasses the lungs and the heart completely. Therefore, residual blood is left stagnant in both the heart and lungs potentially leading to thrombosis and an inadequately unloaded right ventricle. Additionally, the arterial cannulation can lead to problems including but not limited to bleeding, stroke, and infection.
Often, a patient has a problem with the right femoral vein (potentially thrombosis) that prevents transseptal cannulation from the right leg. A 62 cm cannula of the prior art cannot be used to access the left atrium from the left femoral vein because it is often too short. This problem was not recognized until after commercialization. The cannula of the present invention solves that problem.